FDA Adverse Event
Injury
Summary report: N
TRIDENT 10 DEGREE CROSSFIRE INSERT 26 MM ID
MDR report key: 2600487
·
Received May 31, 2012
Report
- Report Number
- 9616680-2012-00405
- Event Type
- Injury
- Date Received
- May 31, 2012
- Report Date
- May 9, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ASSOCIATED DEVICE: (B)(4) OMNIFIT EON CS 127 NKSIZE 4 STEM 23MM 127 NECK, CATALOG #J6097-0425, LOT # UNK. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A REVISION SURGERY TO REPLACE THE INSERT, SCREWS, ZIRCONIA HEAD (OEM PRODUCT (NGK) BY STRYKER (B)(4)) AND STEM DUE TO OSTEOLYSIS WITH A PART OF ACETABULI AND FEMUR. THE TRIAD CUP (OEM PRODUCT (JMM) BY STRYKER (B)(4)) WAS NOT REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 10 DEGREE CROSSFIRE INSERT 26 MM ID | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 10805201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other| R |